Newly Published Research Shows 14-Day Monitoring Detected Almost Three Times More Nonsustained Ventricular Tachycardia Than Standard 48-Hour Monitoring in Patients with Hypertrophic Cardiomyopathy
iRhythm Technologies (NASDAQ:IRTC) announced research results showing that 14-day monitoring using Zio® XT patch detected nearly three times more nonsustained ventricular tachycardia (NSVT) compared to standard 48-hour monitoring in patients with hypertrophic cardiomyopathy (HCM). The study found that 48% of HCM patients experienced NSVT episodes during the 14-day period, with 63% of these episodes detected only after 48 hours. High-risk NSVT was detected in 24% of patients, representing a 3-fold greater diagnostic yield compared to 48-hour monitoring. The findings suggest that traditional short-term monitoring may miss significant cardiac events that could indicate increased risk of sudden cardiac death.
iRhythm Technologies (NASDAQ:IRTC) ha annunciato i risultati di una ricerca che dimostrano che il monitoraggio di 14 giorni utilizzando il patch Zio® XT ha rilevato quasi tre volte più tachicardia ventricolare nonsostenuta (NSVT) rispetto al monitoraggio standard di 48 ore in pazienti con cardiomiopatia ipertrofica (HCM). Lo studio ha rivelato che il 48% dei pazienti con HCM ha sperimentato episodi di NSVT durante il periodo di 14 giorni, con il 63% di questi episodi rilevati solo dopo 48 ore. La NSVT ad alto rischio è stata rilevata nel 24% dei pazienti, rappresentando un aumento di 3 volte nella capacità diagnostica rispetto al monitoraggio di 48 ore. I risultati suggeriscono che il monitoraggio tradizionale a breve termine può perdere eventi cardiaci significativi che potrebbero indicare un rischio aumentato di morte cardiaca improvvisa.
iRhythm Technologies (NASDAQ:IRTC) anunció los resultados de una investigación que muestran que el monitoreo de 14 días utilizando el parche Zio® XT detectó casi tres veces más taquicardia ventricular no sostenida (NSVT) en comparación con el monitoreo estándar de 48 horas en pacientes con cardiomiopatía hipertrófica (HCM). El estudio encontró que el 48% de los pacientes con HCM experimentaron episodios de NSVT durante el período de 14 días, y el 63% de estos episodios se detectaron solo después de 48 horas. La NSVT de alto riesgo fue detectada en el 24% de los pacientes, lo que representa un aumento del 3 veces en el rendimiento diagnóstico en comparación con el monitoreo de 48 horas. Los hallazgos sugieren que el monitoreo tradicional a corto plazo puede perder eventos cardíacos significativos que podrían indicar un aumento del riesgo de muerte súbita cardíaca.
iRhythm Technologies (NASDAQ:IRTC)는 Zio® XT 패치를 사용한 14일 모니터링이 비대성 심근병증(HCM) 환자에서 표준 48시간 모니터링에 비해 거의 3배 더 많은 비지속성 심실 빈맥(NSVT)을 감지했다는 연구 결과를 발표했습니다. 연구에 따르면 HCM 환자의 48%가 14일 기간 동안 NSVT 에피소드를 경험했으며, 이들 에피소드의 63%는 48시간 후에만 감지되었습니다. 고위험 NSVT는 24%의 환자에서 감지되었으며, 이는 48시간 모니터링과 비교하여 진단 수율이 3배 증가한 것을 나타냅니다. 이 결과는 전통적인 단기 모니터링이 갑작스러운 심장 사망의 위험이 증가할 수 있는 중요한 심장 사건을 놓칠 수 있다는 것을 시사합니다.
iRhythm Technologies (NASDAQ:IRTC) a annoncé les résultats d'une recherche montrant que la surveillance de 14 jours avec le patch Zio® XT a détecté près de trois fois plus de tachycardie ventriculaire non soutenue (NSVT) par rapport à la surveillance standard de 48 heures chez des patients atteints de cardiomyopathie hypertrophique (HCM). L'étude a révélé que 48% des patients HCM ont connu des épisodes de NSVT pendant la période de 14 jours, avec 63% de ces épisodes détectés uniquement après 48 heures. La NSVT à haut risque a été détectée chez 24% des patients, représentant un rendement diagnostique trois fois supérieur par rapport à la surveillance de 48 heures. Les résultats suggèrent que la surveillance traditionnelle à court terme peut manquer des événements cardiaques significatifs qui pourraient indiquer un risque accru de mort cardiaque subite.
iRhythm Technologies (NASDAQ:IRTC) hat Forschungsergebnisse bekannt gegeben, die zeigen, dass die 14-tägige Überwachung mit dem Zio® XT Patch nahezu dreimal so viele nicht nachhaltige ventrikuläre Tachykardien (NSVT) entdeckte im Vergleich zur standardmäßigen 48-Stunden-Überwachung bei Patienten mit hypertropher Kardiomyopathie (HCM). Die Studie ergab, dass 48% der HCM-Patienten während des 14-tägigen Zeitraums NSVT-Episoden erlebten, wobei 63% dieser Episoden erst nach 48 Stunden erkannt wurden. Hochrisiko-NSVT wurde bei 24% der Patienten entdeckt, was eine dreifache diagnostische Ertragsrate im Vergleich zur 48-Stunden-Überwachung darstellt. Die Ergebnisse deuten darauf hin, dass traditionelle Kurzzeitüberwachung signifikante kardiale Ereignisse übersehen könnte, die auf ein erhöhtes Risiko für plötzlichen Herztod hinweisen könnten.
- 14-day monitoring showed 2.7x higher diagnostic yield for NSVT detection compared to 48-hour monitoring (48% vs 18%)
- Detection of high-risk NSVT was 3.0x greater over 14 days vs 48 hours (24% vs 8%)
- Study demonstrates superior effectiveness of company's Zio® XT patch for extended monitoring
- None.
Insights
The study reveals a significant advancement in cardiac monitoring for HCM patients, with 14-day monitoring detecting NSVT in
The data strongly supports the superiority of extended monitoring using Zio® XT patch, potentially establishing a new standard of care. For iRhythm Technologies, this represents a significant market opportunity, as current guidelines recommend monitoring every 1-2 years for HCM patients. The study's findings could drive increased adoption of their monitoring solutions and potentially influence insurance coverage policies.
This research strengthens iRhythm's market position in the cardiac monitoring space. The company's Zio® XT device demonstrates clear superiority over traditional 48-hour Holter monitors, addressing a critical medical need in HCM monitoring. With HCM affecting approximately 1 in 500 people, the addressable market is substantial.
The publication in Heart Rhythm Journal and presentations at prestigious conferences add credibility and could accelerate market adoption. The ability to reclassify risk levels in
- Hypertrophic cardiomyopathy (HCM) is a genetic heart condition affecting about 1 in 500 people and is one of the leading causes of sudden cardiac death (SCD) in people under 35, including among athletes.1
- NSVT (nonsustained ventricular tachycardia), a known marker for increased risk of SCD in HCM, was detected in nearly
50% of HCM patients in the study undergoing long-term continuous ambulatory ECG monitoring of up to 14 days with a Zio® XT LTCM ECG patch device;63% of NSVT episodes detected only after 48 hours, suggesting that Holter monitoring would miss the majority of episodes. - NSVT episodes clinically judged to be higher risk were identified in
24% of the study population and were detected more frequently during 14-day monitoring (3-fold greater diagnostic yield vs 48 hours).
SAN FRANCISCO, Oct. 28, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health company focused on creating trusted solutions that detect, predict, and prevent disease, today announced that the results of the Extended Ambulatory ECG Monitoring Enhances Identification of Higher-Risk Ventricular Tachyarrhythmias in Patients with Hypertrophic Cardiomyopathy (EXAMINE-HCM) study have been published in Heart Rhythm Journal. The findings were also presented at the Heart Rhythm Society’s annual meeting in 2023, and most recently, at the International HCM Summit 8 in Boston, MA (October 25-28, 2024).
The newly published research highlights the value of 14-day long-term, uninterrupted2 continuous monitoring (LTCM), using a Zio® XT patch ECG device, for detecting nonsustained ventricular tachycardia (NSVT), a known marker for sudden cardiac death (SCD) in patients with hypertrophic cardiomyopathy (HCM). The findings support more informed decisions about care pathways and interventions, particularly by capturing arrhythmias that would go undetected by standard 48-hour monitoring, such as with a conventional Holter device monitoring period. Prior research has demonstrated that NSVT episodes occurring with higher heart rate, longer duration, and greater frequency are associated with increased risk of SCD3 and practice guidelines place greater emphasis on these episodes (8 consecutive beats, >200 bpm, 2 runs in consecutive 2-day period) in clinical decision-making regarding use of primary prevention implantable cardioverter-defibrillator (ICD).4 These NSVT episodes clinically judged to be higher risk were detected in only
“The EXAMINE-HCM study provides important new insights into how we manage patients with hypertrophic cardiomyopathy identified with ventricular arrhythmias,” said Martin S. Maron, MD, study lead investigator, HCM expert, and Medical Director, Hypertrophic Cardiomyopathy Center, Lahey Hospital and Medical Center. “By extending the monitoring period beyond the traditional 48 hours, we have been able to detect nonsustained ventricular tachycardia episodes that may have otherwise gone undetected with traditional shorter monitoring periods, which may offer the potential to inform more tailored clinical decision-making to help prevent sudden cardiac death in this high-risk population.”
Overall, the study authors concluded that traditional 48-hour short-term cardiac monitoring is significantly less effective compared to extended 14-day continuous monitoring for both NSVT and NVST detection with features judged to be high risk in patients with HCM. These data support the need for additional clinical studies to evaluate the significance of longer-term monitoring for NSVT detection and relationship to future risk for sudden death in HCM.
Key findings from the Extended Ambulatory ECG Monitoring Enhances Identification of Higher-Risk Ventricular Tachyarrhythmias in Patients with Hypertrophic Cardiomyopathy study:
48% of study patients (n=114) with HCM experienced NSVT episodes, and high-risk NSVT was detected in24% (n=56) of study patients during the 14-day monitoring period.63% of NSVT episodes (n=72) were detected during a 3 to 14-day continuous monitoring period, compared to37% (n=42) of NSVT episodes detected during the standard 48-hour Holter monitoring period. This resulted in a 2.7-fold higher diagnostic yield for detecting NSVT during the 14-day extended monitoring period compared to the initial 48 hours (48% vs.18% ; p<0.001).64% of NSVT episodes clinically judged to be higher risk (n=36); 8 consecutive beats, >200 bpm, 2 runs in consecutive 2-day period)) were detected during a 3 to 14-day continuous monitoring period, compared to36% (n=20) of high-risk NSVT episodes detected during the standard 48-hour Holter monitoring period. Therefore, the diagnostic yield of high-risk NSVT was 3.0-fold greater over the entire 2 weeks of monitoring vs. only the first 48 hours (24% vs.8% ; p<0.001).17% of patient profiles were re-classified with respect to risk of sudden cardiac death (n=40) based on their extended 14-day continuous monitoring period. The number of patients at high-risk for SCD increased 2.3-fold (95% CI: 1.2, 4.3) vs. 48-hour monitoring, with 18 (8% ) of study patients reclassified from low- or intermediate-risk to high-risk for SCD. In addition, 22 (9% ) of patients were reclassified from low to intermediate risk.
Importance of Detecting NSVT in HCM Patients
HCM is a genetic condition that affects approximately 1 in 500 people and one of the leading causes of sudden cardiac death (SCD), especially in individuals under 35, including among athletes. HCM is caused by mutations in genes controlling the production of heart muscle proteins, resulting in thickening of the left ventricle wall. These changes can impair the heart’s ability to pump blood efficiently and disrupt its electrical signaling. Nonsustained ventricular tachycardia (NSVT) is a well-recognized marker for SCD risk in patients with HCM.
Standard Holter monitoring captures only up to 48 hours of data, potentially missing episodes of NSVT that can occur later. This study shows that extended monitoring can detect NSVT that would otherwise go unnoticed, providing clinicians with clinical actionable information needed to make timely interventions such as implantable cardioverter-defibrillators (ICDs).
The findings underscore the importance of long-term continuous monitoring (LTCM) for patients with HCM. By detecting NSVT that would otherwise go undetected, clinicians are better equipped to assess sudden cardiac death (SCD) risk and recommend interventions like ICD placement.
This study highlights the value of extended monitoring as an important tool for risk stratification in HCM patients, complementing current American Heart Association/American College of Cardiology guidelines, which recommend monitoring every 1 to 2 years but do not yet specify the optimal duration for detecting arrhythmias.
“There is an abundance of clinical evidence demonstrating that uninterrupted, continuous, patch-based monitoring with the Zio® long-term continuous monitoring service leads to increased diagnostic yield of Afib, atrial arrhythmias, ventricular arrhythmias, more accurate ectopic burden estimation, and lower rates of retesting,”5 said Mintu Turakhia, MD, iRhythm’s Chief Medical and Scientific Officer and EVP, Product Innovation. “This study adds to the evidence by showing how ascertainment of NSVT could be missed during risk stratification, in this case specifically for hypertrophic cardiomyopathy, depending on the diagnostic test being used.”
About the Study
The EXAMINE-HCM study was a single-center, prospective study focused on patients with hypertrophic cardiomyopathy (HCM), a common genetic heart disease and a leading cause of sudden cardiac death (SCD) in young adults. The study aimed to evaluate the prevalence and clinical profile of nonsustained ventricular tachycardia (NSVT), a key marker for SCD risk, using extended continuous ambulatory ECG monitoring. The primary goal was to assess the benefit of long-term monitoring compared to traditional 48-hour Holter monitoring, with a focus on NSVT episodes of longer duration, greater frequency, and occurring with a higher heart rate, which have been associated greater risk of SCD.
The study enrolled 236 consecutive adult patients diagnosed with HCM (mean age 49 ± 12 years;
NSVT was defined as more than 3 consecutive ventricular beats at a rate of ≥120 beats per minute (bpm) lasting for less than 30 seconds and terminating spontaneously. High-risk NSVT episodes were defined as those with one or more of the following: ≥8 consecutive beats, a rate of >200 bpm, or ≥2 runs within a 48-hour period, all of which are associated with a higher risk of SCD.
The study's primary objective was to compare the prevalence, burden, speed, and length of NSVT episodes detected during the initial 48-hour period (standard Holter monitoring) versus the full 14-day extended monitoring period.
Key outcomes included the detection of NSVT with features judged to be higher risk and its potential impact on SCD risk stratification. The European Society of Cardiology (ESC) SCD risk score was calculated based on both the 48-hour and full 14-day data, and patients were stratified into low, intermediate, and high-risk SCD categories over a 5-year period.
This project was supported by an investigator-initiated grant from iRhythm Technologies, Inc. Results presented are scientific data and not product or marketing claims.
Zio XT is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue or anxiety.
To learn more about the study, visit Heart Rhythm. To learn more about the value of the Zio LTCM service, which has been demonstrated in over 100 original scientific research manuscripts6, visit iRhythmTech.com..
About iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. To learn more about iRhythm, including its portfolio of Zio products and services, please visit irhythmtech.com.
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1 “Hypertrophic Cardiomyopathy (HCM).” Www.Heart.Org, American Heart Association, Aug. 2024, www.heart.org/en/health-topics/cardiomyopathy/what-is-cardiomyopathy-in-adults/hypertrophic-cardiomyopathy.
2 “Uninterrupted” refers to uninterrupted ECG recording.
3 Wang W, Lian Z, Rowin EJ, Maron BJ, Maron MS, Link MS. Prognostic implications of nonsustained ventricular tachycardia in high-risk patients with hypertrophic cardiomyopathy. Circ Arrhythm Electrophysiol. 2017;10.
4 Ommen et al. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR Guideline for the Management of Hypertrophic Cardiomyopathy: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 4;149(23):e1239-e1311.
5 Reynolds et al. Comparative effectiveness and healthcare utilization for ambulatory cardiac monitoring strategies in Medicare beneficiaries. Am Heart J. 2024;269:25–34. Accessed January 2, 2024. https://doi.org/10.1016/j.ahj.2023.12.002
6 Data on file. iRhythm Technologies, 2023: https://www.irhythmtech.com/providers/evidence/list-of-clinical-articles
FAQ
What were the key findings of iRhythm's (IRTC) EXAMINE-HCM study?
How much more effective was IRTC's 14-day monitoring compared to standard 48-hour monitoring?
What percentage of patients were reclassified for sudden cardiac death risk using IRTC's extended monitoring?
